The Phase I trial passed without any adverse event on six healthy volunteers and its Russian partner, Pharmsynthez, has now started Phase II where 12 patients will receive escalating dosing levels to establish the safe dose level for MyeloXen.
The final element of the trial will test the dosing range for further safety, surrogate efficacy and mode of action analysis.
MyeloXen has been formulated using Xenetic’s ImuXen liposomal entrapment technology and is one of up to six candidates being investigated under a Co-Development Agreement between Xenetic and St Petersburg–based Pharmsynthez. The global market for MS treatments is currently estimated to be worth US$20bn.
Scott Maguire, Xenetic’s chief executive, said: “The move to dosing MS patients represents an important milestone in this clinical trial. We now have all our platform technologies as represented by their respective products at least in Phase II clinical trials.
“We are encouraged with the announcement yesterday on the commencement of the ErepoXen Phase III trial for the treatment of anaemia, where our Russian partners are now making significant progress on our collaboration. We expect to make further announcements on additional clinical candidates in due course.”